QC Scientist

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Job Description

QC SCIENTIST (100%)

About the role :

This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the Quality Control teams within a world-class Biotech GMP manufacturing environment.

The job holder is accountable for life cycle management activities of analytical assays performed in the QC laboratories of Neuchâtel - Switzerland with a focus on laboratory investigations. In addition, the job holder also leads laboratory method validations and verification, transfers, improvement projects and supports complex multi-sites investigations.

How you will contribute :

• Comply with GMP requirements, Takeda policies and applicable QC procedures

• Identify and facilitate/lead problem-solving and improvement projects using DMAIC approach

• Investigation owner and coordinator (out-of-specification, out-of-limit, and out-of-trend analytical results, and other types of investigations)

• Responsible for writing validation or verification protocols and reports for analytical methods

• Responsible for writing qualification plans and reports for critical reagents and reference standards

• Oversee validation and qualification activities executed by analysts, provide training and support

• Support of analytical method transfers as transferring or receiving unit between R&D and Analytical Laboratories as well as within Operations

• Write assignment plans and reports for method controls, establish and perform evaluation of control charts

• Support and preparation of audits, audit responses and regulatory submissions

• Participate in multi-site projects as local project lead, working in collaboration with other QC scientists and Analytical Development groups

What you bring to Takeda :

• University or engineering degree in analytical chemistry, biotechnology or biochemistry

• Good skills in microbiology field is a plus

• At least 5 years of experience in GMP pharma business activities, preferably in the scope of recombinant therapeutic product in pharmaceutical environment

• More than 2 years of experience in GMP laboratory activities

• Proven experience and knowledge in analytical method validation and verification

• Good knowledge of critical reagent qualification

• Experience in problem solving (facilitation and application of DMAIC tools) and deviation management

• Strong knowledge of regulatory requirements concerning analytical test methods and licenses

• Fluent in French and English (C1 written and spoken)

• Proficiency in all aspects of standard IT tools

• Good Knowledge of advanced statistical tools (i.e. hypothesis/relationship testing, control charting, capability, design of experiments, multivariate data analysis)

• Able to set his/her own priorities and tight timelines

• Good interpersonal, organizational, and communication skills

• Ability to synthesize information and defend conclusions publically

What Takeda can offer you:

• Attractive salaries

• Full accident cover

• Participation in health insurance premiums

• Advantageous retirement plans

• Subsidized meal

• Financial participation in the sports practices of its employees

• Transportation: support in local public transport, free parking, carpooling program

• Takeda Neuchâtel offers to its employees an attractive framework and working conditions. The well-being, safety, development and career development of its employees are at the heart of our vision and of our Human Resources, Health, Environment and Safety policies.

• Takeda Neuchâtel is an employer committed to its employees and future generations.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status.

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